BR112018008017A2 - composição farmacêutica, método de preparação de composição farmacêutica líquida, kit farmacêutico, sistema de fornecimento de injeção - Google Patents

composição farmacêutica, método de preparação de composição farmacêutica líquida, kit farmacêutico, sistema de fornecimento de injeção

Info

Publication number
BR112018008017A2
BR112018008017A2 BR112018008017A BR112018008017A BR112018008017A2 BR 112018008017 A2 BR112018008017 A2 BR 112018008017A2 BR 112018008017 A BR112018008017 A BR 112018008017A BR 112018008017 A BR112018008017 A BR 112018008017A BR 112018008017 A2 BR112018008017 A2 BR 112018008017A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
supply system
pharmaceutical
kit
injection supply
Prior art date
Application number
BR112018008017A
Other languages
English (en)
Other versions
BR112018008017B1 (pt
Inventor
Mariau Jérémie
Thiry Michel
Original Assignee
Iltoo Pharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Iltoo Pharma filed Critical Iltoo Pharma
Publication of BR112018008017A2 publication Critical patent/BR112018008017A2/pt
Publication of BR112018008017B1 publication Critical patent/BR112018008017B1/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • A61K38/2013—IL-2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Communicable Diseases (AREA)
  • Transplantation (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

a presente invenção refere-se a uma composição farmacêutica líquida de il-2 e seu uso no tratamento de distúrbios autoimunes e inflamatórios. também são descritos métodos de preparação da mencionada composição e dispositivos de fornecimento cheios com a mencionada composição.
BR112018008017-9A 2015-10-22 2016-10-20 Composição farmacêutica líquida, uso de uma composição farmacêutica líquida, método de preparação de uma composição farmacêutica líquida, kit farmacêutico e sistema de fornecimento de injeçãosubcutânea BR112018008017B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15306696 2015-10-22
EP15306696.4 2015-10-22
PCT/EP2016/075204 WO2017068031A1 (en) 2015-10-22 2016-10-20 Pharmaceutical compositions of il-2

Publications (2)

Publication Number Publication Date
BR112018008017A2 true BR112018008017A2 (pt) 2018-10-23
BR112018008017B1 BR112018008017B1 (pt) 2023-10-10

Family

ID=54360399

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018008017-9A BR112018008017B1 (pt) 2015-10-22 2016-10-20 Composição farmacêutica líquida, uso de uma composição farmacêutica líquida, método de preparação de uma composição farmacêutica líquida, kit farmacêutico e sistema de fornecimento de injeçãosubcutânea

Country Status (13)

Country Link
US (2) US10722460B2 (pt)
EP (1) EP3364944B1 (pt)
JP (2) JP7038655B2 (pt)
KR (1) KR20180064536A (pt)
CN (1) CN108135841B (pt)
AU (1) AU2016341241B9 (pt)
BR (1) BR112018008017B1 (pt)
CA (1) CA3001429C (pt)
HK (1) HK1259454A1 (pt)
IL (1) IL258366B (pt)
MX (1) MX2018004883A (pt)
WO (1) WO2017068031A1 (pt)
ZA (1) ZA201802199B (pt)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20190129077A (ko) 2017-03-15 2019-11-19 팬디온 테라퓨틱스, 인코포레이티드 표적화된 면역관용
CN111010866A (zh) 2017-05-24 2020-04-14 潘迪恩治疗公司 靶向免疫耐受性
US10946068B2 (en) 2017-12-06 2021-03-16 Pandion Operations, Inc. IL-2 muteins and uses thereof
US10174091B1 (en) 2017-12-06 2019-01-08 Pandion Therapeutics, Inc. IL-2 muteins
KR20210021357A (ko) * 2018-06-13 2021-02-25 아크론 바이오테크놀로지 엘엘씨 액체 약학적 조성물에서 매우 안정한 치료적으로 활성인 알데스루킨의 제조 방법
EP3836954A1 (en) 2018-08-13 2021-06-23 Iltoo Pharma Combination of interleukin-2 with an interleukin 1 inhibitor, conjugates and therapeutic uses thereof
AU2020279240A1 (en) 2019-05-20 2021-12-23 Pandion Operations, Inc. MAdCAM targeted immunotolerance
IL293628A (en) 2019-12-12 2022-08-01 Iltoo Pharma Interleukin 2 chimeric structures
KR102653906B1 (ko) 2020-01-14 2024-04-03 신테카인, 인크. 편향된 il2 뮤테인 방법 및 조성물
WO2021168079A1 (en) 2020-02-21 2021-08-26 Pandion Operations, Inc. Tissue targeted immunotolerance with a cd39 effector
IL311883A (en) 2021-10-06 2024-06-01 Assist Publique H?Pitaux De Paris Interleukin 2 chimeric constructs with targeted specificity for inflammatory tissues
WO2024056154A1 (en) 2022-09-12 2024-03-21 INSERM (Institut National de la Santé et de la Recherche Médicale) Interleukin-2 for use in treating autism spectrum disorder
CN117883376B (zh) * 2024-03-14 2024-06-25 北京四环生物制药有限公司 含重组人白细胞介素-2的药物制剂及其制备方法

Family Cites Families (17)

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US4752A (en) * 1846-09-10 Augustus hamann
CA1341562C (en) 1982-03-31 2007-11-27 Tadatsugu Taniguchi Gene coded for interleukin-2 polypeptide, recombinant dna carrying the said gene, a living cell line possessing the recombinant dna, and method for producing interleukin-2 using the said cell
FI82266C (fi) 1982-10-19 1991-02-11 Cetus Corp Foerfarande foer framstaellning av il-2 -mutein.
WO1985000817A1 (en) 1983-08-10 1985-02-28 Amgen Microbial expression of interleukin ii
WO1985004328A1 (en) * 1984-03-28 1985-10-10 Cetus Corporation Pharmaceutical compositions of microbially produced interleukin-2
US4530787A (en) * 1984-03-28 1985-07-23 Cetus Corporation Controlled oxidation of microbially produced cysteine-containing proteins
JPS60243021A (ja) * 1984-03-28 1985-12-03 シタス　コ−ポレイシヨン システイン含有蛋白質の制御された酸化方法
US4656132A (en) 1984-03-28 1987-04-07 Cetus Corporation Method of improving the yield of heterologous protein produced by cultivating recombinant bacteria
US4752585A (en) 1985-12-17 1988-06-21 Cetus Corporation Oxidation-resistant muteins
CA1340265C (en) 1985-01-18 1998-12-15 Kirston E. Koths Oxidation resistant muteins
US4748234A (en) 1985-06-26 1988-05-31 Cetus Corporation Process for recovering refractile bodies containing heterologous proteins from microbial hosts
JP2003517462A (ja) 1999-07-22 2003-05-27 アベンティス・ファーマスーティカルズ・インコーポレイテツド 複数回投与用エリスロポエチン製剤
AU2006200923A1 (en) 1999-12-30 2006-03-30 Novartis Vaccines And Diagnostics, Inc. Methods for pulmonary delivery of interleukin-2
JP2003519175A (ja) 1999-12-30 2003-06-17 カイロン コーポレイション インターロイキン−２の肺送達のための方法
ATE367167T1 (de) * 2005-02-07 2007-08-15 Novartis Vaccines & Diagnostic Aufbereitung von aldesleukin zur pharmazeutischen verwendung
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Also Published As

Publication number Publication date
ZA201802199B (en) 2019-01-30
MX2018004883A (es) 2018-08-01
AU2016341241B2 (en) 2021-10-28
CA3001429C (en) 2023-07-11
EP3364944A1 (en) 2018-08-29
AU2016341241A1 (en) 2018-05-10
US11883531B2 (en) 2024-01-30
JP2022008792A (ja) 2022-01-14
US20210128465A1 (en) 2021-05-06
US20180303754A1 (en) 2018-10-25
JP7329571B2 (ja) 2023-08-18
JP7038655B2 (ja) 2022-03-18
BR112018008017B1 (pt) 2023-10-10
CN108135841B (zh) 2024-03-05
WO2017068031A1 (en) 2017-04-27
RU2018118215A3 (pt) 2020-02-21
AU2016341241B9 (en) 2021-11-18
CA3001429A1 (en) 2017-04-27
US10722460B2 (en) 2020-07-28
CN108135841A (zh) 2018-06-08
JP2018537423A (ja) 2018-12-20
IL258366A (en) 2018-06-28
HK1259454A1 (zh) 2019-11-29
EP3364944B1 (en) 2024-06-12
KR20180064536A (ko) 2018-06-14
IL258366B (en) 2021-10-31
RU2018118215A (ru) 2019-11-25

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

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B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 20/10/2016, OBSERVADAS AS CONDICOES LEGAIS